MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-4800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144); Regurgitation (2259); Obstruction/Occlusion (2422); Abdominal Cramps (2543); Patient Problem/Medical Problem (2688)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 20-feb-2019.The physician confirmed the explanted device will not be return to apollo for analysis.Device labeling addresses the reported event as follows: precautions: placement of the balloon within the stomach produces a delay in gastric emptying and this can create a variety of expected and predictable reactions including a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed throughout the entire placement duration.Most patients acclimate to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced after placement, physicians should prescribe proton pump inhibitors (ppis) and antiemetics prophylactically and consider prescribing antispasmodics or anticholinergic medications for cramping due to accommodation of the balloon, and/or prokinetic medications for symptoms due to the delay in gastric emptying).Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms.The physiological response of the patient to the presence of orbera¿ may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications of the use of orbera¿ include: gastric outlet obstruction.A partially-filled balloon (i.E., <400 cc), or a leaking balloon could lead to gastric outlet obstruction, requiring balloon removal.It is also possible for a fully filled (400-700 cc) balloon to impair the gastric outlet, which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require early removal.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach, delayed gastric emptying and/or the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Gastroesophageal reflux.Bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.Warnings: each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration, gastric and esophageal perforation and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.

Event Description

Reported as: a patient with the orbera intragastric balloon reported nausea, vomiting, and stomach cramps after every meal and complained symptoms of delayed gastric emptying.Upon physician examination, the balloon appeared to be too low in the abdomen, settling in the pylorus.Physician manually manipulated the balloon back into place.Patient was feeling better that day but experienced acid reflux.The next day patient called the physician and stated the previously reported symptoms having restarted.The patient was instructed to be on liquid diet only and to lay down on the left side.The next day patient felt better but continued to experience nausea.Physician decided to explant the balloon.The device was removed.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 8355374
• MDR Text Key: 136718834
• Report Number: 3006722112-2019-00011
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF01905
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 86